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Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck (TAXT-XRT)


OBJECTIVES:

- Determine the maximum tolerated dose of docetaxel when administered with concurrent
boost radiotherapy in patients with advanced squamous cell carcinoma of the head and
neck previously treated with induction chemotherapy.

- Determine the toxicity of this treatment regimen in this patient population.

- Determine the efficacy of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of docetaxel.

Patients receive docetaxel IV over 1 hour weekly for 4 weeks. Patients also undergo
hyperfractionated radiotherapy daily, 5 days a week, for 4 weeks followed by radiotherapy
alone twice daily for 2 weeks.

Upon completion of chemoradiotherapy, patients not achieving complete response to induction
chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of
radiotherapy.

Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated
dose (MTD) is reached. The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients
experience dose limiting toxicity. Additional patients are treated at the MTD.

Patients are followed monthly for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) or its
variants (e.g., lymphoepithelioma or undifferentiated epidermoid carcinoma)

- Stage III or IV (M0) disease

- Must have had prior platinum/fluorouracil based initial induction chemotherapy (may
have included a taxane)

- Previously untreated disease prior to induction regimen

- Received 1-3 courses of chemotherapy and less than 7 weeks from the beginning of
the last course of induction therapy

- Evaluable disease during induction therapy required

- No prior head and neck carcinoma except if treated with surgery as sole modality at
least 2 years prior to study

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Greater than 3 months

Hematopoietic:

- WBC at least 3,000/mm^3 OR

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

- SGOT less than 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase less than 2.5 times ULN

- Bilirubin normal

- SGOT no greater than 2 times ULN

Renal:

- Not specified

Cardiovascular:

- No acute cardiac dysrhythmias or unstable cardiac condition (e.g., angina)

Other:

- No other concurrent malignancy within the past 3 years except curatively treated
limited basal or squamous cell skin cancer or carcinoma in situ of the cervix

- Adequate and nutritionally balanced enteral intake (at least 1,800 kcal/day)

- No persistent diarrhea

- No peripheral neuropathy of any etiology greater than grade 2

- No other serious illness or medical condition

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- At least 5 years since any other form of prior chemotherapy

Endocrine therapy:

- Prior hormonal therapy allowed

Radiotherapy:

- No prior radiotherapy for SCCHN

Surgery:

- See Disease Characteristics

- Percutaneous endoscopic gastrostomy required prior to radiotherapy

Other:

- No IV alimentation as primary source of calories

- Completely recovered from prior diagnostic or therapeutic procedures

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Roy B. Tishler, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068118

NCT ID:

NCT00006107

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent salivary gland cancer
  • stage III salivary gland cancer
  • stage IV salivary gland cancer
  • salivary gland squamous cell carcinoma
  • recurrent lymphoepithelioma of the nasopharynx
  • recurrent lymphoepithelioma of the oropharynx
  • stage III lymphoepithelioma of the nasopharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • stage IV lymphoepithelioma of the oropharynx
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115